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National Statement on Ethical Conduct in Research Involving Humans
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2007-9-21
来源：中国人类遗传资源平台
PLEASE NOTE
This
Statement entitled the National Statement on Ethical Conduct in Research Involving Humans (‘the
Statement’) consists of a series of Guidelines made in accordance with the National Health and
Medical Research Council Act 1992 (‘the Act’).
The
Statement has revised the guidelines entitled the NHMRC Statement on Human Experimentation and
Supplementary Notes in accordance with section 90 of the Act, with the exception of Supplementary
Notes 5 and 7, which have not yet been revised. This Statement therefore replaces the NHMRC
Statement on Human Experimentation and Supplementary Notes with the exception of Supplementary
Notes 5 and 7 which remain in force from the date they were originally issued in October 1983 and
November 1992 respectively.
In
addition:
(1)
Despite the changes to the guidelines affecting Institutional Ethics Committees,
any committee established under Supplementary Note 1 of the NHMRC Statement on Human
Experimentation and Supplementary Notes 1992 (the previous Statement) and in existence immediately
before the commencement of this Statement shall continue in existence as if established under 2.
Human Research Ethics Committees of this Statement, and any matter being undertaken by such a
committee prior to commencement of this Statement may be continued by that committee.
(2)
Persons who, immediately before commencement of this Statement, had been members
of an Institutional Ethics Committee established under the previous Statement are to be taken, with
effect from the commencement of this Statement, to have been duly appointed to a Human Research
Ethics Committee under this Statement and to be entitled to continue in office as members of that
committee until 31 December 1999. From 1 January 2000 all Human Research Ethics Committees must be
constituted in accordance with this Statement.
CONTENTS
PREAMBLE
Importance
of ethics
Purpose of
this Statement
Historical context
Statutory
considerations
The meaning
of ethics and of research
Structure
and interpretation
1、PRINCIPLES
OF ETHICAL CONDUCT
Integrity, respect for persons, beneficence and justice 11
Consent
Research
merit and safety
Ethical
review and conduct of research
2、HUMAN
RESEARCH ETHICS COMMITTEES
Composition
Appointment of members
Procedures
Advocates and interpreters
Expedited review for minimal risk research
Recording of decisions
Monitoring
Complaints
Suspension or discontinuation of research
Compliance
reports to the National Health and Medical Research Council
3.MULTI-CENTRE RESEARCH
Review
Monitoring
CONTENTS
4.
RESEARCH INVOLVING CHILDREN AND YOUNG PEOPLE
5.
RESEARCH INVOLVING PERSONS WITH AN INTELLECTUAL OR MENTAL
IMPAIRMENT
6.
RESEARCH INVOLVING PERSONS HIGHLY DEPENDENT ON MEDICAL CARE
Emergency
care research
Intensive care research
Neonatal
intensive care research
Terminal care research
Research involving persons with impaired capacity for communication
Research involving unconscious persons
Human
Research Ethics Committee consideration of research proposals involving persons highly dependent on
medical care
7.
RESEARCH INVOLVING PERSONS IN DEPENDENT OR UNEQUAL
RELATIONSHIPS
8.
RESEARCH INVOLVING COLLECTIVITIES
9.
RESEARCH INVOLVING ABORIGINAL AND TORRES STRAIT ISLANDER
PEOPLES
10. RESEARCH
INVOLVING IONISING RADIATION
11. RESEARCH
INVOLVING ASSISTED REPRODUCTIVE TECHNOLOGY
12. CLINICAL
TRIALS
13.
INNOVATIVE THERAPY OR INTERVENTION
14.EPIDEMIOLOGICAL RESEARCH CONTENTS
15. USE
OF HUMAN TISSUE SAMPLES
Respect for
persons
Institutional responsibility
Where
consent would be required
Where the
requirement for consent could be waived
Confidentiality
16. HUMAN
GENETIC RESEARCH
Social
significance and consequences of genetic research
Privacy and
confidentiality
Consent
Where
the requirement for consent could be waived
Genetic counselling
17. RESEARCH
INVOLVING DECEPTION OF PARTICIPANTS, CONCEALMENT OR COVERT OBSERVATION
18. PRIVACY
OF INFORMATION
19.
INTELLECTUAL PROPERTY
APPENDIX 1
RELEVANT PUBLICATIONS
International Declarations and Conventions
International Guidelines and Codes
National Health and Medical Research Council Publications
Other
56
APPENDIX 2
INFORMATION PRIVACY PRINCIPLES
APPENDIX 3
GLOSSARY OF DEFINITIONS
ABBREVIATIONS